Biopharma
A biopharma plant prints two kinds of labels. In vitro diagnostic reagents, and products regulated as devices, are designed and printed with UDI software. Vaccines, therapeutic antibodies, and recombinant proteins carry the product name, strength, lot, expiry, and storage conditions.
Reagents used for blood screening and regulated as drugs are handled like drug labels. Line labeling for reagents and device-regulated products is on Medical device UDI. After drug labels reach the warehouse, receiving and shipping are on Pharma distribution.
Reagents and device-regulated products
Kits, the lowest sale unit, and the carton are designed and printed with UDI software. Class III in vitro diagnostic reagents already carry a unique device identifier. From 1 June 2027, newly produced Class II devices (including in vitro diagnostic reagents) and Class I in vitro diagnostic reagents do too. From 1 June 2029, Class I devices do too.
The product identifier is what the company has already filed with the regulatory authority. Lot, serial, and dates come from that production run. Text and the symbol sit on the same label. Build the template in LuckDesign, preview, then print locally. Line labeling, and the lot and expiry check when goods enter or leave, are on Medical device UDI.
Vaccines, antibodies, and recombinant proteins
Vial, small-box, and shipper labels carry the name, strength, lot, expiry, and storage temperature. Vials, prefilled syringes, small boxes, and shippers use the same fields, with a layout for each size. Build the template in LuckDesign, preview, then print locally.
Reagents used for blood screening and regulated as drugs follow this same label. Cold, frozen, and keep-dark go on that label. After the goods reach the warehouse, receiving, shipping, and cold-chain carton labels are on Pharma distribution.
What each label carries
- Kit and lowest sale unit: product identifier, lot, production date or expiry, with text a person can read beside it.
- Reagent carton: the same fields, on a layout sized for the carton.
- Vial, prefilled syringe, and small box: name, strength, lot, expiry, and storage temperature.
- Drug shipper: the same lot and expiry as the small box, on a layout sized for the carton.
- Blood-screening reagents regulated as drugs: lot, expiry, and storage temperature, the same way as the drug label.
Check which label it is
- Decide whether the label is for a reagent or for a drug.
- For reagents and device-regulated products, build the template in UDI software.
- For drugs, build the template around name, strength, lot, expiry, and storage temperature. Blood-screening reagents regulated as drugs use this template too.
- Make a separate layout for the lowest sale unit and the carton. Use the same fields.
- Scan a sample with the device on the line.
- Install LuckDesign for local printing. When the line submits the print job from its system, use LuckNext.
Whether a product is a device or a drug, and the date a unique device identifier is required, follow the regulatory authority at the time.
Focus areas
Reagent identifier
Design and print with UDI software. Line labeling is on Medical device UDI.
Drug label
Name, strength, lot, expiry, and storage temperature, in a LuckDesign template.
In the warehouse
Receiving, shipping, and cold-chain carton labels are on Pharma distribution.